International consensus to define outcomes for trials of chemoradiotherapy for anal cancer (CORMAC-2): defining the outcomes from the CORMAC core outcome set
Summary: Variation in outcomes definitions and reporting limit the utility of clinical trial results. The Core Outcome Research Measures in Anal Cancer (CORMAC) project developed a core outcome set (COS) for chemoradiotherapy trials for anal squamous cell carcinoma (ASCC) through an international he...
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| Format: | Article | 
| Language: | English | 
| Published: | Elsevier
    
        2024-12-01 | 
| Series: | EClinicalMedicine | 
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2589537024005182 | 
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| author | Robert Samuel Stephen R. Knight Richard Adams Prajnan Das Jennifer Dorth David Finch Marianne G. Guren Maria A. Hawkins Susan Moug Lakshmi Rajdev David Sebag-Montefiore Andrew G. Renehan Rebecca Fish Miguel A. Rodriguez-Bigas Pratik Adusumilli Ahmed Allam Mohamed Mario Alvarez Gallego Eva Angenete Ane Appelt Maaike Berbee Danielle Brogden Peter Brown Lucy Buckley Nathalie Casanova Rachel Cooper Nuno Couto Peter Coyne Tamzin Cuming Charlotte Deijin Kristopher Dennis Cathy Eng Alexandra Gilbert Duncan Gilbert Karyn Goodman Rashmi Jadon Anders Johnsson Arunansu Kar Ethan Ludmir Marie-Louise Lydrup Ivan Lyra-Gonzalez Stefania Manfrida Rebecca Muirhead Sarah O'Dwyer Thomas Rackley Lukasz Raszewski Leslie Samuel Mark Saunders Andrew Scarsbrook Eva Segelov Timothy Simmons Paul Sutton Nicholas Symons Deborah Williamson | 
| author_facet | Robert Samuel Stephen R. Knight Richard Adams Prajnan Das Jennifer Dorth David Finch Marianne G. Guren Maria A. Hawkins Susan Moug Lakshmi Rajdev David Sebag-Montefiore Andrew G. Renehan Rebecca Fish Miguel A. Rodriguez-Bigas Pratik Adusumilli Ahmed Allam Mohamed Mario Alvarez Gallego Eva Angenete Ane Appelt Maaike Berbee Danielle Brogden Peter Brown Lucy Buckley Nathalie Casanova Rachel Cooper Nuno Couto Peter Coyne Tamzin Cuming Charlotte Deijin Kristopher Dennis Cathy Eng Alexandra Gilbert Duncan Gilbert Karyn Goodman Rashmi Jadon Anders Johnsson Arunansu Kar Ethan Ludmir Marie-Louise Lydrup Ivan Lyra-Gonzalez Stefania Manfrida Rebecca Muirhead Sarah O'Dwyer Thomas Rackley Lukasz Raszewski Leslie Samuel Mark Saunders Andrew Scarsbrook Eva Segelov Timothy Simmons Paul Sutton Nicholas Symons Deborah Williamson | 
| author_sort | Robert Samuel | 
| collection | DOAJ | 
| description | Summary: Variation in outcomes definitions and reporting limit the utility of clinical trial results. The Core Outcome Research Measures in Anal Cancer (CORMAC) project developed a core outcome set (COS) for chemoradiotherapy trials for anal squamous cell carcinoma (ASCC) through an international healthcare professional and patient consensus process. The CORMAC-COS comprises 19 outcomes across 4 domains (disease activity, survival, toxicity, life impact). In CORMAC-2 we have established standardised definitions for the 11 disease activity and survival outcomes in the CORMAC COS. Definitions were agreed through a 3 step process, initially identifying existing definitions through systematic review (registered with PROSPERO, CRD42016036540), using these to populate a two-round Delphi questionnaire completed by 51 experts from 13 countries, and finally ratification through an online consensus meeting. Standardising the definitions for these core outcomes facilitates real world utilisation of the CORMAC-COS, thereby increasing the quality of data available for clinical decision-making and ultimately enhancing patient care. | 
| format | Article | 
| id | doaj-art-13141decd4db43eeae1e82431775d0e8 | 
| institution | Kabale University | 
| issn | 2589-5370 | 
| language | English | 
| publishDate | 2024-12-01 | 
| publisher | Elsevier | 
| record_format | Article | 
| series | EClinicalMedicine | 
| spelling | doaj-art-13141decd4db43eeae1e82431775d0e82024-12-07T08:28:12ZengElsevierEClinicalMedicine2589-53702024-12-0178102939International consensus to define outcomes for trials of chemoradiotherapy for anal cancer (CORMAC-2): defining the outcomes from the CORMAC core outcome setRobert Samuel0Stephen R. Knight1Richard Adams2Prajnan Das3Jennifer Dorth4David Finch5Marianne G. Guren6Maria A. Hawkins7Susan Moug8Lakshmi Rajdev9David Sebag-Montefiore10Andrew G. Renehan11Rebecca Fish12Miguel A. Rodriguez-BigasPratik AdusumilliAhmed Allam MohamedMario Alvarez GallegoEva AngeneteAne AppeltMaaike BerbeeDanielle BrogdenPeter BrownLucy BuckleyNathalie CasanovaRachel CooperNuno CoutoPeter CoyneTamzin CumingCharlotte DeijinKristopher DennisCathy EngAlexandra GilbertDuncan GilbertKaryn GoodmanRashmi JadonAnders JohnssonArunansu KarEthan LudmirMarie-Louise LydrupIvan Lyra-GonzalezStefania ManfridaRebecca MuirheadSarah O'DwyerThomas RackleyLukasz RaszewskiLeslie SamuelMark SaundersAndrew ScarsbrookEva SegelovTimothy SimmonsPaul SuttonNicholas SymonsDeborah WilliamsonNIHR Manchester Biomedical Research Centre, Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK; University of Leeds, Leeds Institute for Medical Research, St. James's University Hospital, Leeds, UKCentre for Medical Informatics, Usher Institute, University of Edinburgh, Edinburgh, UK; School of Health and Wellbeing, University of Glasgow, Glasgow, UKCentre for Trials Research, Cardiff University School of Medicine, Cardiff, UKUniversity of Texas MD Anderson Cancer Center, USADepartment of Radiation Oncology, University Hospitals Cleveland Medical Centre, Cleveland, USANIHR Manchester Biomedical Research Centre, Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK; Colorectal and Peritoneal Oncology Centre, The Christie NHS FT, ManchesterDepartment of Oncology, Oslo University Hospital, Institute of Clinical Medicine, University of Oslo, Oslo, NorwayDepartment of Medical Physics and Biomedical Engineering, University College London, London, UKDepartment of Colorectal Surgery, Royal Alexandra Hospital, Paisley, UKTisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USAUniversity of Leeds, Leeds Institute for Medical Research, St. James's University Hospital, Leeds, UKNIHR Manchester Biomedical Research Centre, Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK; Colorectal and Peritoneal Oncology Centre, The Christie NHS FT, ManchesterNIHR Manchester Biomedical Research Centre, Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK; Colorectal and Peritoneal Oncology Centre, The Christie NHS FT, Manchester; Corresponding author. NIHR Manchester Biomedical Research Centre, Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, UK.Summary: Variation in outcomes definitions and reporting limit the utility of clinical trial results. The Core Outcome Research Measures in Anal Cancer (CORMAC) project developed a core outcome set (COS) for chemoradiotherapy trials for anal squamous cell carcinoma (ASCC) through an international healthcare professional and patient consensus process. The CORMAC-COS comprises 19 outcomes across 4 domains (disease activity, survival, toxicity, life impact). In CORMAC-2 we have established standardised definitions for the 11 disease activity and survival outcomes in the CORMAC COS. Definitions were agreed through a 3 step process, initially identifying existing definitions through systematic review (registered with PROSPERO, CRD42016036540), using these to populate a two-round Delphi questionnaire completed by 51 experts from 13 countries, and finally ratification through an online consensus meeting. Standardising the definitions for these core outcomes facilitates real world utilisation of the CORMAC-COS, thereby increasing the quality of data available for clinical decision-making and ultimately enhancing patient care.http://www.sciencedirect.com/science/article/pii/S2589537024005182Core outcome setOutcomesAnal cancerConsensusDelphiChemoradiotherapy | 
| spellingShingle | Robert Samuel Stephen R. Knight Richard Adams Prajnan Das Jennifer Dorth David Finch Marianne G. Guren Maria A. Hawkins Susan Moug Lakshmi Rajdev David Sebag-Montefiore Andrew G. Renehan Rebecca Fish Miguel A. Rodriguez-Bigas Pratik Adusumilli Ahmed Allam Mohamed Mario Alvarez Gallego Eva Angenete Ane Appelt Maaike Berbee Danielle Brogden Peter Brown Lucy Buckley Nathalie Casanova Rachel Cooper Nuno Couto Peter Coyne Tamzin Cuming Charlotte Deijin Kristopher Dennis Cathy Eng Alexandra Gilbert Duncan Gilbert Karyn Goodman Rashmi Jadon Anders Johnsson Arunansu Kar Ethan Ludmir Marie-Louise Lydrup Ivan Lyra-Gonzalez Stefania Manfrida Rebecca Muirhead Sarah O'Dwyer Thomas Rackley Lukasz Raszewski Leslie Samuel Mark Saunders Andrew Scarsbrook Eva Segelov Timothy Simmons Paul Sutton Nicholas Symons Deborah Williamson International consensus to define outcomes for trials of chemoradiotherapy for anal cancer (CORMAC-2): defining the outcomes from the CORMAC core outcome set EClinicalMedicine Core outcome set Outcomes Anal cancer Consensus Delphi Chemoradiotherapy | 
| title | International consensus to define outcomes for trials of chemoradiotherapy for anal cancer (CORMAC-2): defining the outcomes from the CORMAC core outcome set | 
| title_full | International consensus to define outcomes for trials of chemoradiotherapy for anal cancer (CORMAC-2): defining the outcomes from the CORMAC core outcome set | 
| title_fullStr | International consensus to define outcomes for trials of chemoradiotherapy for anal cancer (CORMAC-2): defining the outcomes from the CORMAC core outcome set | 
| title_full_unstemmed | International consensus to define outcomes for trials of chemoradiotherapy for anal cancer (CORMAC-2): defining the outcomes from the CORMAC core outcome set | 
| title_short | International consensus to define outcomes for trials of chemoradiotherapy for anal cancer (CORMAC-2): defining the outcomes from the CORMAC core outcome set | 
| title_sort | international consensus to define outcomes for trials of chemoradiotherapy for anal cancer cormac 2 defining the outcomes from the cormac core outcome set | 
| topic | Core outcome set Outcomes Anal cancer Consensus Delphi Chemoradiotherapy | 
| url | http://www.sciencedirect.com/science/article/pii/S2589537024005182 | 
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